RECRUITING

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and/or other behaviors to escape or avoid unwanted thoughts, feelings, and/or urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH/NIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.

Official Title

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: a Randomized Clinical Trial

Quick Facts

Study Start:2025-01-22
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06648629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Living with HIV
  2. * Drink at unhealthy levels based on self-reported answers to the AUDIT-C, referencing drinking over the previous 3 months \[score of ≥4 (men) or ≥3 (women) will be used to identify eligible participants\]
  3. * on HIV treatment and are
  4. * 18 years or older.
  5. * Read at an 8th grade level
  6. * Can provide a physical address
  7. * Able to provide informed consent
  1. * Anyone with a score = 12 on the AUDIT-C will be excluded.
  2. * Anyone with a score ≥20 on the PHQ-9, indicative of severe depression, will be excluded.
  3. * Anyone with a score of ≥15 on the GAD-7, indicative of severe anxiety, will be excluded.

Contacts and Locations

Study Contact

Sarah E Woolf-King, PhD
CONTACT
314-443-2354
sewoolf@syr.edu
Stephen A Maisto, PhD
CONTACT
samaisto@syr.edu

Study Locations (Sites)

Syracuse University
Syracuse, New York, 13244
United States

Collaborators and Investigators

Sponsor: Syracuse University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-01-22
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Alcohol
  • ACT
  • Treatment

Additional Relevant MeSH Terms

  • HIV-1-infection
  • Alcohol Drinking